Sealing device

ABSTRACT

A percutaneously insertable system for sealing punctures in blood vessels includes an element that is percutaneously insertable into and deplorable within a blood vessel, a thread-like member attached to the element that passes through the wall of the blood vessel and arresting element movable on the thread and into engagement with the other surface of the blood vessel thereby to seal the opening.

RELATED APPLICATIONS

[0001] This application is a continuation of copending application Ser.No. 09/617,286, filed Jul. 17, 2000, which is a continuation ofapplication Ser. No. 08/837,965, filed Apr. 14, 1997, now U.S. Pat. No.6,190,400, issued Feb. 20, 2001, which is a continuation of Ser.No.08/369,264, filed Jan. 5, 1995, now U.S. Pat. No. 5,620,461, issuedApr. 15, 1997, which is a continuation of application Ser. No.08/187,788, filed Jan. 26, 1994, which is a continuation of applicationSer. No. 07/781,091, filed Oct. 22, 1991.

BACKGROUND OF THE INVENTION

[0002] The invention is concerned with a sealing device for the closureof puncture holes in blood vessels.

[0003] In the case of invasive investigations and intervention inmedical practice, it is necessary that access be gained to the system ofblood vessels in question (arterial or venous). This can take placesurgically by direct vision or by way of percutaneous puncture wherebythe blood vessel must first be located “blind” with a hollow needle(so-called feeling with the needle). After feeling with the needle, atracer is then inserted through the needle into the blood vessel. Whenthe positioning of the tracer has been verified, the needle is removedover the tracer. Next, a dilator is pushed in over the tracer with theobjective of making the puncture opening large enough to position aso-called “sheath” or “introducer” in the blood vessel. This sheathconsists of a hollow tube made of plastic whereby one extremity, whichis open, is pushed up into the blood vessel and the other extremity,which is sealed by a so-called “hemostatic valve”, is left outside thebody. The hemostatic valve is made of rubber and is designed in such away that objects (in particular, tracers and catheters) can be insertedthrough it into the sheath and can then be withdrawn again through itwithout this leading to blood being lost out of the sheath. The dilatoris removed after the sheath has been inserted into the blood vessel bypassing it over the dilator. In this way, an access route to the bloodvessel remains open through which tracers, catheters etc. can beinserted with ease. The sheath is removed from the blood vessel afterthe procedure is finished. As a result, an opening remains in the bloodvessel (the so-called puncture site) through which blood can flow to theoutside (bleeding). In order to stanch bleeding from the puncture site,the blood vessel must be closed by applying pressure (pressing) in orderto allow time for the blood clotting mechanism to form a clot at thepuncture site. Depending on whether the patient has had larger orsmaller amounts of anti-clotting agents (anticoagulants), the time overwhich pressure has to be applied varies, in the case of an arterialpuncture, from 15 minutes to more than an hour. Once the bleeding hasstopped, an elastic bandage (pressure bandage) is placed over the siteof the puncture; this exerts pressure to as to prevent the blood clotfrom being washed away by the pressure in the blood vessel which caneasily happen, especially in the case of an arterial puncture. Thispressure bandage must remain in place for some time, varying from clinicto clinic from 8 to 24 hours. During the period of time that thepressure bandage is in place, the patient must remain resting in bed.After removing the pressure bandage, the patient can become mobileagain. After an intra-arterial examination, this usually means, inpractice, that the patient must stay in the hospital overnight and thengo home the following morning.

[0004] The procedure is associated with quite a few complications whichare inherent in the technique which is currently used. Thus intensebleeding can occur in addition to aneurysms (outward swellings of thewall of the blood vessel at the site of the puncture) andpseudo-aneurysms (whereby a passage exists, via the puncture site,between the lumen of the blood vessel and a clot situated around theblood vessel (hematoma). Arteriovenous fistulas (passages between thearterial and venous systems of blood vessels) can also arise.Neighboring nerves can also become pinched if bleeding is sufficientlyprofuse, resulting in pain, sensation disturbances or even paralysis ofthe groups of muscles which are innervated by these nerves. Thesecomplications arise in approximately 1% of all procedures. Surgicalintervention is sometimes necessary whereby the hematoma is relieved andpuncture site is sutured over (and, if required, any fistula is sealed).

SUMMARY OF THE INVENTION

[0005] In accordance with the invention, a means is envisaged to provideimmediate closure of the puncture site by means of a sealing devicewhich is introduced into the blood vessel through a sheath. This sealingdevice must be of such a form that it lies in the puncture site in astable manner, does not seal the lumen of the blood vessel, does notcause intraluminal thrombi and decomposes after a certain period of timewithout causing emboli to form. In addition, repeated puncture of thesame segment of the blood vessel must remain a possibility and theremust be no allergic reactions to the material used. Of course, thematerial used must also be non-toxic and must be biocompatible.

[0006] This objective is achieved in accordance with the invention bymeans of a sealing device for the closure of openings in blood vesselswhich comprises an element that is capable of unfolding, which isintroduced into the blood vessel, together with a fixation attachmentconnected to it. In this way, the element which is capable of unfoldingcan even serve as a sealing element if it is constructed in the form ofa flexible sheet. However, it is also possible to use a tubular elementas the sealing device that is pushed into the blood vessel. In addition,it is possible to construct the sealing element in the form of aninflatable element. The fixation attachment preferably consists of athread. In the event that a flexible sheet is used as the sealingelement which is introduced into the blood stream, then, in accordancewith a preferred embodiment of the invention, an arresting element isapplied over the fixation attachment on the outside of the blood vessel.

[0007] The elements and/or the fixation attachment in accordance withthe invention preferably consist of bioresorbable material. An exampleof this is collagen. In the event that the fixation attachment comprisesa fixation thread, the bioresorbable material is, for example, the samematerial that is used for surgical suturing thread, e.g., catgut orpolyglactin.

[0008] The sealing device is also termed an occluder in the followingspecification.

[0009] In an embodiment of the occluder in accordance with theinvention, the sealing element—also called a plug—is designed in such away that it unfolds in the blood vessel after passing through the sheathand can, therefore, no longer come out again. In such an embodiment, theplug is preferably essentially circular, heart-shaped or oval. Thefixation attachment or the fixation thread remains on the outside of theblood vessel in such an embodiment and is held in place by the skin. Thefixation attachment is positioned through the site of the puncture.During removal of the sheath, the plug which has been inserted into theblood vessel is carefully pulled back toward the puncture site. Thefixation attachment is preferably positioned essentially in the centerof the flat sheet or in the vicinity thereof. The plug completely sealsoff the puncture site after the sheath has been removed. The fixationattachment can then be sutured to the skin.

[0010] In another embodiment, the sealing element is applied to theblood vessel from the outside and the element which is capable ofunfolding is inserted into the blood vessel in order to provide a meansof fastening the fixation attachment to which the sealing element isjoined. In such an embodiment, it is not necessary that the elementwhich is capable of unfolding has a flat, sheet-like form; on thecontrary, it can take any form as long as satisfactory points of contactare provided on the inside of the blood vessel. In such a case, thesealing element can comprise a displaceable, tubular part which passestightly over the fixation attachment and which is moved by the wall ofthe blood vessel. This type of arrangement can be effected by means of atube or a small pipe.

[0011] The material of the plug, in particular collagen, causes a clotto form locally that is located in contact with the internal or externalwall of the blood vessel; the material is completely resorbed during thecourse of time, usually over a period of several weeks.

[0012] Spontaneous resorption also takes place over a period of severalweeks when using the preferred embodiment of the invention, i.e., a plugof collagen and a resorbable fixation attachment.

[0013] The invention is explained in more detail below by means ofexamples of embodiments which are reproduced in the drawings.

DESCRIPTION OF THE DRAWINGS

[0014]FIG. 1 shows a side view of a first embodiment of the sealingdevice in accordance with the invention;

[0015]FIG. 2 shows the same embodiment seen from above;

[0016]FIG. 3 shows the introduction of the sealing device into a bloodvessel in accordance with FIG. 1 and 2;

[0017]FIG. 4 shows the sealing device introduced into a blood vessel inaccordance with the aforementioned embodiment;

[0018]FIGS. 5a, b and c show a view from above of further embodiments ofthe sealing device in accordance with the invention;

[0019]FIG. 6 shows a further embodiment of the sealing device introducedinto a blood vessel in accordance with the invention;

[0020]FIGS. 7a, b and c show parts of a further embodiment of thesealing device in accordance with the invention;

[0021]FIG. 8 shows the sealing device introduced into a blood vessel inaccordance with FIG. 7, and

[0022]FIG. 9 shows a further embodiment of the sealing device inaccordance with the invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0023] A first embodiment of the sealing device in accordance with theinvention is shown in the form of a side view in FIG. 1. This comprisesa flexible sheet 1 as the sealing element and, in the center connectedthereto, a fixation attachment 2, fashioned here in the form of athread. The same arrangement is sketched in the form of a view fromabove in FIG. 2.

[0024] A blood vessel 8 is illustrated in FIG. 3 in which a sheath 6 hasbeen introduced as is carried out for various types of medicalapplications. After removing the sheath 6, the problem existed until nowthat a considerable opening arose in the blood vessel which had to besealed in some way. The means described in the prior art for effectingsuch sealing have been found to be unreliable or to impose restrictionson the patient in terms of his or her movement. In accordance with theinvention, the device portrayed in FIGS. 1 and 2 is inserted through thesheath as illustrated. After the sealing element 1 has been introducedinto the blood vessel 8, the sheet 1 which is capable of unfoldingunfolds in such a way that its surface area is greater than the surfacearea of the opening which is to be sealed. The sheath 6 is next movedout of the opening whereupon this will become somewhat smaller. Bypulling on the fixation thread 2, sheet 1 will come into contact withthe blood vessel 8 as illustrated in FIG. 4. By manufacturing both sheet1 and the fixation attachment 2 from resorbable material, it isguaranteed that these parts will disappear (e.g., after a period ofseveral weeks) after the opening in the blood vessel has been closed byhealing.

[0025] Various other embodiments of the flexible, sealing element orplug 1 are illustrated in FIGS. 5a, b and c. These can be used dependingon the opening made in the blood vessel and depending on the particularpossibilities available for inserting them through the sheath.

[0026]FIG. 6 portrays a further embodiment of the sealing device inaccordance with the invention. This is largely in conformity with thesealing device described by means of the above figures except that anarresting ring 10 is applied over the fixation thread 2. This arrestingring 10 serves to define the position of the sealing element 1 in aprecise manner and is also manufactured from a biologically resorbablematerial. The ring 10 has an internal diameter such that, on the onehand, it can slide smoothly over the fixation attachment 2 but, on theother hand, it provides some degree of grip between the two parts.

[0027]FIGS. 7a, b and c show a further sealing device in accordance withthe invention. The part joined to the fixation attachment is indicatedby the number 11 in this embodiment. Just as in the precedingembodiments, part 11 is an element which is capable of unfolding that isto be introduced into the blood vessel but, in contrast to the previousembodiments, it does not serve as a sealing element. The chamfered tubeindicated by the reference number 12 serves as the sealing element. Thistube 12 is provided with an opening 13 for accommodating a thread 2. Ablood vessel 8 is illustrated in FIG. 8 with the sealing deviceintroduced therein in accordance with FIG. 7. It is apparent that theelement 11, which is capable of unfolding, has been introduced into theblood vessel and that the thread 2 extends through the opening. The tube2 is moved through the wall of the blood vessel by means of a small pipeor similar arrangement and provides sealing. For this, the opening 13 ofthe tube 12 and the external diameter of the fixation thread 2 arearranged in such a manner relative to one another that, on the one hand,movement is possible with respect to one another but, on the other hand,fastening of the tube is achieved. In this embodiment, tube 12preferably consists of biologically resorbable material and has, inparticular, blood clotting properties. The healing process at theopening in the blood vessel 8 is promoted in this way.

[0028]FIG. 9 illustrates a further embodiment of the sealing element ina blood vessel 8 in accordance with the invention. In this way, use canbe made of the element 11 which is capable of unfolding that was shownby means of FIG. 7. Here, however, an inflatable balloon 14 ispositioned over the fixation thread 2 instead of the tube 12. Suchpositioning (of the balloon) can also take place by means of a smallpipe or similar arrangement. After moving the balloon 14 downward as faras is possible, it is inflated (via line 16) by means of an inflationdevice 15, which is merely depicted schematically, whereby sealing ofthe opening in the blood vessel 8 occurs on the one hand, and a morecomplete clamping of the balloon 14 onto the thread 2 is produced on theother hand.

[0029] It is understood that the embodiments described above are merelyexamples and that the invention is not limited to these examples. Thusthe fixation attachment can comprise all agents and means known in theprior art and is not limited to the thread illustrated in the drawings.In addition, the element which is capable of unfolding that is to beintroduced into the blood vessel can comprise all configurations whichcan possibly be imagined.

[0030] The invention is also concerned with the use of bioresorbablematerial for the manufacture of a sealing device for the closure ofpuncture holes in blood vessels as described above.

[0031] The superb action/properties of the sealing device in accordancewith the invention will be illustrated by means of the results of invitro and in vivo tests which are described below.

[0032] In-Vitro Tests

[0033] Goal

[0034] to test the occluder with regard to:

[0035] 1. the strength of the joint between the fixation thread and theplug, directly after insertion and after 1 hour;

[0036] 2. The pressure resistance of the occluder, directly and after 1hour;

[0037] 3. “freedom from leakage of blood”, directly and after 1 hour;

[0038] 4. its effectiveness during movement;

[0039] 5. its effectiveness at various diameters of the opening;

[0040] 6. the unfolding of the plug;

[0041] 7. the liquid flow pattern and pressure reduction zones aroundthe occluder (turbulence);

[0042] 8. the frequency of embolization;

[0043] in order to provide a measure for the degree of effectiveness ofthe occluder, the occlusion frequency is determined as a function ofinsertion frequency, (i.e., the ratio of the number of effectiveocclusions to the number of times the occluder is inserted).

[0044] Test arrangements

[0045] All tests are carried out using fresh, heparin treated blood.

[0046] The following parameters are known for the blood which is used:

[0047] the hemoglobin concentration (Hb);

[0048] the hematocrit value (Ht);

[0049] the concentration of thrombocytes;

[0050] the thrombo-test value (TT);

[0051] the cephalin time.

[0052] Test arrangement for tests 1 through 5

[0053] The central feature of the test arrangement is an artery of atest animal (dog, pig) with a diameter of approximately 7 mm. This issealed at both ends—at one end by means of a clip and at the other endby means of a tap. The lumen of the artery is joined, via this tap, to asachet of blood which is placed in a pressure bag. The pressure in theblood vessel is kept constant at 150 mm Hg. A sheath with an internaldiameter of 9 French (2.9 mm) is inserted into the artery usingconventional techniques. The maximum diameter of the plug has thestandard value of 4.0 mm.

[0054] The insertion module is made in such a way that it can beinserted through a standard sheath with an internal diameter of 5 French(1.65 mm).

[0055] The following investigations are carried out using this testarrangement.

[0056] 1. The strength of the joint between the fixation thread and theplug, directly after insertion and after 1 hour. Goal: to test thestrength of the fixation thread, the connection between the fixationthread and the plug and the deformability of the plug under theinfluence of a force exerted from the outside. Method: this test iscarried out by hanging a weight of 250 grams onto the fixation threadfor a period of 15 minutes.

[0057] 2. The pressure resistance of the occluder, directly and after 1hour. Goal: to test the mechanical strength and deformability of theplug under the influence of a force exerted from the inside. Method:this test is carried out by increasing the pressure in the blood vesselto 300 mm Hg for a period of 15 minutes.

[0058] 3. “Freedom from leakage of blood”, directly and after 1 hour.Goal: to examine the quantity of blood which seeps through the plugplaced in the opening even though the plug is positioned properly from amechanical point of view. Method: this measurement is combined with test2. The quantity of blood which diffuses through the plug is measured bycollecting the blood on dry pieces of gauze and weighing the pieces ofgauze before and after the experiment. The difference in weight in gramsis taken to be the quantity of blood, in ml, which has diffused.

[0059] 4. The effectiveness of the occluder during movement. Goal: totest the stability of the plug during movements of the blood vessel.Method: the blood vessel is fixed at one end and an oscillating bar ishung at the other end. This bar is moved by an electric motor with afrequency of 1 Hz. A small bar is placed transversely across the bloodvessel at a distance of about 2 cm from the site of the puncture in sucha way that it acts as a site at which the blood vessel is hinged. Thepositioning of the blood vessel is such that the part connected to thebar describes the segment of a circle between 0 and 150 degrees. Thepuncture site is located in the moving part of the blood vessel. Theduration of the test is 30 minutes.

[0060] 5. The effectiveness of the occluder at various diameters of thepuncture opening. Goal: to test the effectiveness of the occluder atvarious diameters of the puncture opening. Method: standard plugs with across section of 4 mm are inserted after puncture sites have beengenerated using the following internal sheath diameters: 5 French (1.65mm), 7 French (2.3 mm) and 9 French (2.9 mm). These tests take placeunder standard conditions and are evaluated in terms of the ratio ofocclusions/insertions (O/I ratio: 100% success = 1.0; 0% success = 0).

[0061] Test arrangement for tests 6 through 8

[0062] The central feature of the test arrangement is an artery derivedfrom a test animal (dog, pig) with a cross section of about 7 mm. Thearrangement also comprises a peristaltic pump, a heat exchanger, apressure vessel, a hemofilter and a collection vessel. The blood ispumped from the collection vessel (i.e., at atmospheric pressure)through the peristaltic pump to the pressure vessel. The pressure vesselis partly filled with air. The liquid can be held under pressure bymeans of a valve, which can be regulated, that is located at the top ofthe pressure vessel. Air bubbles which are also possible pumped out ofthe collection vessel can be caught and trapped in the pressure vessel.The blood flows from the pressure vessel to the artery via a heatexchanger. Two pressure lines are introduced into the artery (before andafter the plug) together with a junction point for measuringtemperatures. A hemofilter and a resistor which can be regulated arelocated behind the vessel. The temperature is held at 37° C. during theexperiment and the pressure in front of the plug is held at 150 mm Hg.Using a measuring cylinder and a stop watch, the flow rate can bemeasured after passage of the blood through the hemofilter locatedbehind the blood vessel, beyond the resistor, before the blood flowsback into the collection vessel.

[0063] If necessary, the blood vessel can be supported on the outside bymeans of a (plastic) tube in order to simulate the pressure of tissues.The site for the puncture opening is thus left accessible. Use can bemade of a standard, color Doppler Echo apparatus for the evaluation offlow rates and flow patterns.

[0064] The following experiments are carried out using this testarrangement.

[0065] 6. The unfolding of the plug. Goal: to test whether the plugunfolds in accordance with expectations. Method: attempts are made torender the plug visible by means of echography and to establish itsshape.

[0066] 7. The liquid flow pattern and pressure reduction zones aroundthe occluder (turbulence). Goal: to check that the plug does not causestenosis. Method: the plug is inserted after the initial measurements ofpressure and flow have been made. After insertion of the plug, thesemeasurements are repeated in order to check whether the plug causesstenoses. In addition, the flow pattern around the plug is made visibleby means of the color Doppler Echo technique.

[0067] 8. The frequency of embolization. Goal: to check that the plugdoes not act as a source of embolization. Method: each time a plug isinserted, blood is allowed to circulate for a period of 2 hours. Afterthis time, the hemofilter is checked and renewed. The pores of thehemofilter are the same in size as those of filters used duringextracorporeal circulation. The number, size and (if possible)composition of the emboli are recorded.

[0068] Tests 6, 7 and 8 can be carried out simultaneously. Tests 6 and 7are carried out both at the beginning of the investigations and justbefore the end of the tests.

[0069] In Vivo Tests

[0070] The following aspects are of importance in in vivo tests.

[0071] the stability of the plug;

[0072] the frequency at which bleeding occurs at the location of thepuncture site;

[0073] the effect of rapid mobilization (of the patient) on thestability of the plug;

[0074] the healing of the wall of the blood vessel at the location ofthe puncture site;

[0075] the formation of aneurysms at the location of the puncture site;

[0076] the frequency at which stenoses of the blood vessels occur at thelocation of the plug;

[0077] the resorption of the plug and the fixation thread as a functionof time;

[0078] scar formation around the plug and the fixation thread;

[0079] the thrombogenetic action of the plug;

[0080] the frequency of embolization caused by the material of the plug;

[0081] the occurrence of infections at the location of the plug site;

[0082] the toxicity of the plug and the fixation thread.

[0083] Any animal of adequate size can serve as the test animal (dog,pig). After adequate anesthesia and respiratory connection, a catheteris introduced into the a. carotis in order to record pressure. Theprocess of treating with heparin takes place by intravenouslyadministering 100 U/kg of body weight. Blood samples are taken for thedetermination of hemoglobin (Hb), the hemocrit value (Ht), thrombocytes,thrombo-test (TT) values and the cephalin time.

[0084] A blood vessel of adequate diameter is now located (a. iliaca,aorta). An initial angiogram of the blood vessel which is to bepunctured is recorded by means of a catheter in the a. carotis. Astandard 9 French sheath is inserted followed by the insertion of astandard plug (diameter 4 mm).

[0085] One or more puncture sites can be used depending on the size ofthe blood vessel which has been selected. After inserting the plug,checks are made over a period of 15 minutes as to whether the plugremains stable at its location and whether or not there is “oozing” atthe location of the puncture site (this evaluation issemi-quantitative). After the procedure, a check angiograph is made ofthe punctured segment of the blood vessel before removing the sheathfrom the a. carotis. In the event of survival (of the test animal),blood samples are taken the following day for the determination of Hband Ht. In addition, a clinical examination is made for signs of emboli.A check angiograph is made of the punctured segment of the blood vesselbefore termination. After termination, the puncture site is located,removed and fixed in formalin (for optical microscopy) or glutaraldehyde(for scanning electron microscopy, SEM).

[0086] Survival periods (are selected to be): 0, 1, 7, 30, 90 and 180days.

[0087] A control group consists of test animals which have undergone thesame procedure except for the arterial puncture.

[0088] The results of both in vivo and in vitro tests show that thesealing device in accordance with the invention is superbly well suitedfor the application envisaged.

We claim:
 1. An assembly for introduction into an incision and forsealing an opening in the wall of a blood vessel having a vessel wallwith inner and outer wall surfaces, said assembly comprising: a sheatharranged to be placed inside said incision and directed to the openingin the wall of the blood vessel; an occlusion element, arranged to beinserted through said sheath into and through the opening in the wall ofthe blood vessel; a retaining thread having a distal section and aproximal section, said distal section being arranged to be insertedthrough said sheath into and through the opening in the wall of theblood vessel, said distal section being attached to said occlusionelement, said proximal section being arranged to remain proximal to theopening in the blood vessel, whereupon a portion of said retainingthread bridges the wall of the blood vessel through the opening, saidretaining thread being further arranged to apply force to said occlusionelement to cause the engagement of said occlusion element with the innerwall surface of the blood vessel; and a locking element, arranged to beslidably mounted on said retaining thread to apply force to the outerwall surface of the blood vessel to produce tension in said retainingthread confined to the portion of said retaining thread bridging thewall of the blood vessel.
 2. The assembly of claim 1, wherein saidocclusion element and said retaining thread are resorbable.
 3. Theassembly of claim 2 wherein said locking element is resorbable.
 4. Anassembly for introduction into an incision and for sealing an opening inthe wall of a blood vessel having a vessel wall with inner and outerwall surfaces, said assembly comprising; a sheath arranged to be placedinside said incision and directed to the opening in the wall of theblood vessel; a first resorbable segment having a distal section and aproximal section, said distal section being arranged to be insertedthrough said sheath into and through the opening in the wall of theblood vessel; a second resorbable segment attached to said distalsection of said first resorbable section and arranged to be insertedthrough said sheath into and through the opening in the wall of theblood vessel, said proximal section of said first resorbable segmentbeing arranged to remain proximal to the opening in the wall of theblood vessel, whereupon a portion of said first resorbable segmentbridges the wall of the blood vessel through the opening, said firstresorbable segment being further arranged to apply force to said secondresorbable segment to cause the engagement of said second resorbablesegment with the inner wall surface of the blood vessel; a thirdresorbable segment arranged to be slidably mounted on said firstresorbable segment to apply force to the outer wall surface of the bloodvessel to produce tension in said first resorbable segment confined tothe portion of said first resorbable segment bridging the wall of theblood vessel.
 5. The assembly of claim 4, wherein said second resorbablesegment comprises an occlusion element which causes the sealing of saidopening.
 6. The assembly of claim 4, wherein said second resorbablesegment comprises a spreadable element which causes the sealing of saidopening.
 7. An assembly for introduction into an incision and forsealing an opening in the wall of a blood vessel having a vessel wallwith inner and outer wall surfaces, the wall having a wall thicknessbetween the inner and outer wall surfaces, said assembly comprising; afirst member arranged to be placed inside the incision and directed tothe opening in the wall of the blood vessel; an occlusion element,arranged to be inserted through said first member into and through theopening in the wall of the blood vessel; a retaining thread having adistal section and a proximal section, said distal section beingarranged to be inserted through the first member into the opening in thewall of the blood vessel, said distal section being attached to saidocclusion element, said proximal section being arranged to remainproximal to the opening in the blood vessel, whereupon a portion of saidretaining thread bridges the wall thickness through the opening, withsaid retaining thread being further arranged to apply force to saidocclusion element to cause the engagement of said occlusion element withthe inner wall surface of the blood vessel; and a locking elementarranged to be slidably mounted on said retaining thread to apply forceto the outer wall surface of the blood vessel to produce tension in saidretaining thread confined to the portion of said retaining threadbridging the wall thickness of the blood vessel.
 8. The assembly ofclaim 7, wherein said occlusion element and said retaining thread areresorbable.
 9. The assembly of claim 8 wherein said locking element isresorbable.
 10. A bioabsorbable occlusion assembly for introduction intoan incision and for sealing an opening in the wall of a blood vesselhaving a vessel wall with inner and outer wall surfaces, the bloodvessel being located beneath the skin, said assembly comprising; anocclusion element which is sized to be fitted through the opening in thewall of the blood vessel and to lie generally adjacent to the inner wallsurface during use; a retaining thread sized for reception in theincision and in operative connection with said occlusion element toextend proximally of the occlusion element through the incision; and alocking element sized to be received in the incision and beneath theskin and operatively connected to and maintaining tension upon saidretaining thread to retain the wall of the blood vessel between saidlocking element and said occlusion element during use.
 11. The assemblyof claim 10, wherein said occlusion element is spreadable.
 12. A sealingdevice for percutaneously sealing a percutaneously made puncture in ablood vessel having a vessel wall with inner and outer wall surfaces,said sealing device comprising an occlusion element which is constructedand arranged to be percutaneously inserted into the blood vessel; aretaining thread connected to the occlusion element, said occlusionelement being repositionable after insertion into the blood vessel toengage against the inner wall surface; and a locking element constructedand arranged to be inserted percutaneously and be moved over theretaining thread toward and adjacent the outer wall surface of the bloodvessel and into cooperative relation with said occlusion element tothereby seal the puncture in the blood vessel.
 13. A method of sealingan incision and an opening in a blood vessel having a vessel wall withinner and outer wall surfaces creating a wall thickness between thesurfaces, wherein the incision extends through the skin of a patient,and wherein the opening comprises a percutaneously made puncture in theblood vessel, said method comprising the steps of: supplying anocclusion system comprising a first member, a first resorbable segment,a second resorbable segment, and a third resorbable segment, said firstresorbable segment comprising a distal section and a proximal section,said distal section being operatively coupled to said second resorbablesegment, said proximal section being arranged to remain proximal to theopening in the blood vessel; inserting said first member into saidincision and directed to the opening in the wall of the blood vessel;inserting said first resorbable segment and said second resorbablesegment through said first member into and through the opening in thewall of the blood vessel; applying a force on said proximal section ofsaid first resorbable segment, said force applied on said proximalsection causing the engagement of said second resorbable segment withthe inner wall surface of the blood vessel, whereupon a portion of saidfirst resorbable segment bridges the wall thickness; and sliding saidthird resorbable segment along said first resorbable segment to applyforce to the outer wall surface of the blood vessel to produce tensionin said first resorbable segment confined to the portion of said firstresorbable segment bridging the wall thickness of the blood vessel. 14.The method of claim 13, wherein said second resorbable segment comprisesan occlusion element which causes the sealing of the opening.
 15. Themethod of claim 13, wherein said second resorbable segment comprises aspreadable element which causes the sealing of the opening.
 16. Themethod claim 13, wherein said first member comprises a sheath.
 17. Amethod of sealing an incision and an opening in a blood vessel, whereinthe incision extends through the skin of a patient, and wherein theopening comprises a percutaneously made puncture in the blood vessel,the blood vessel having a vessel wall with inner and outer wall surfacescreating a wall thickness between the surfaces, said method comprisingthe steps of: supplying an occlusion system comprising a first member, afirst resorbable segment, a second resorbable segment, and a thirdresorbable segment, said first resorbable segment comprising a distalsection and a proximal section, said distal section being operativelycoupled to said second resorbable segment, said proximal section beingarranged to remain proximal to the opening in the blood vessel;inserting said first member into said incision and directed to theopening in the wall of the blood vessel, wherein the insertion of saidfirst member causes the insertion of said first resorbable segment andsaid second resorbable segment into and through the opening in the wallof the blood vessel; applying a force on said proximal section of saidfirst resorbable segment, said force causing the engagement of saidsecond resorbable segment with the inner wall surface of the bloodvessel, whereupon a portion of said first resorbable segment bridges thewall thickness; sliding said third resorbable segment along said firstresorbable segment to apply force to the outer wall surface of the bloodvessel to produce tension in said first resorbable segment confined tothe portion of said first resorbable segment bridging the wall thicknessof the blood vessel.
 18. The method of claim 17, wherein said secondresorbable segment comprises an occlusion element which causes thesealing of the opening.
 19. The method of claim 17, wherein said secondresorbable segment comprises a spreadable element which causes thesealing of the opening.
 20. The method of claim 17, wherein said firstmember comprises a sheath.